FDA Adverse Event
Other
Summary report: N
SMARTPLUG
MDR report key: 557022
·
Received April 30, 2004
Report
- Report Number
- 2031959-2004-00010
- Event Type
- Other
- Date Received
- April 30, 2004
- Report Date
- April 29, 2004
- Manufacturer
- MEDENNIUM, INC.
- Product Code
- LZU
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE FOLLOWING STATEMENT WAS DOCUMENTED IN MEDENNIUM'S CONTACT US CONTROLLED FORM, UNDER THE PRODUCT EXPERIENCE REPORT SECTION, BY MEDENNIUM FOR DR. "THE DOCTOR REPORTED THAT SHE IMPLANTED THE SMARTPLUG IN THE LOWER PUNCTA OF A MIDDLE AGE PT WITH SEVERE DRY EYE. THE PT CAME BACK TWO WEEKS LATER WITH SIGNS OF INFECTION (DISCHARGE, REDNESS, AND PAIN) IN ONE EYE. THE DOCTOR FLUSHED THE PLUG OUT AND GAVE THE PT ORAL ANTIBIOTIC. FOUR WEEKS LATER THE SECOND EYE HAD A SIMILAR REACTION TO THE SMARTPLUG AND THE DOCTOR PERFORMED THE SAME PROCEDURE. AFTER A MONTH THE PT WAS DOING FINE. MEDENNIUM ASKED THE DOCTOR IF SHE WAS SURE ON THE INFECTION. THE DOCTOR WAS NOT SURE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTPLUG | PUNCTUM PLUG | LZU | MEDENNIUM, INC. | MODEL 500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |